Safety, Tolerability, Pharmacokinetics And Pharmacodynamics of SUVN-I6107 In Healthy Participants

NCT06705088 | Recruiting Phase 1 FDA Drug

• 1 other identifier: S1-I6107
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is 1) to investigate how safe and tolerable SUVN-I6107 is after a single oral dose at increasing dose levels and multiple oral doses at increasing dose levels, 2) to determine the pharmacokinetic (PK) profile after single and multiple ascending oral doses, 3) to investigate the effects of food on SUVN-I6107 pharmacokinetics and 4) to evaluate the pharmacodynamic (PD) effects of single and multiple ascending oral doses of SUVN-I6107 on quantitative electroencephalogram (qEEG) and event-related potential (ERP) assessments.

Conditions

Healthy

Keywords

SUVN-I6107; First-in-Human; Muscarinic M1 Receptor Positive Allosteric Modulator (M1-PAM)

Outcome Measures

Primary Outcomes (7)

• Number of participants with treatment-related adverse events

  Number of participants with adverse events (AE), discontinuations due to AE or serious adverse event \[SAE\], and withdrawals from the study due to AE.

  From Day 1 to Day 11 (Segment 1) and from Day 1 to Day 24 (Segment 2)

• Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values

  Descriptive statistics of QTcF for observed values and changes from baseline will be summarized at each scheduled time point.

  From Baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)

• Number of Participants With Clinically Significant Changes in Blood Pressure

  From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)

• Number of Participants With Clinically Significant Changes in Pulse Rate

  From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)

• Number of Participants With Clinically Significant Changes in Body Temperature

  From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)

• Number of Participants With Clinically Significant Changes in Respiration Rate

  From baseline to Day 11 (Segment 1) and to Day 24 (Segment 2)

• Changes in Columbia Suicide Severity Rating Scale (C-SSRS) Score

  The C-SSRS includes 'yes' or 'no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). Greater lethality or potential lethality of suicidal behaviors (endorsed on the behavior subscale) indicates increased risk.

  From baseline to Day 24 (Segment 2)

Secondary Outcomes (4)

• Area under the concentration-time curve (AUC)

  Day 1 and Day 14

• Maximum observed concentration (Cmax)

  Day 1 and Day 14

• Time to reach maximum concentration (Tmax)

  Day 1 and Day 14

• Terminal half-life (t½)

  Day 1 and Day 14

Other Outcomes (2)

• Quantitative electroencephalogram (qEEG)

  Day 1 (Segment 1); Day 7 and Day 12 (Segment 2)

• Latency for parameter from the Active, Auditory Oddball Event-related potential (ERP) test

  Day 1 (Segment 1); Day 7 and Day 12 (Segment 2)

Study Arms (2)

Single Ascending Dose

EXPERIMENTAL

single ascending doses administered orally

Drug: SUVN-I6107; Drug: Placebo

Multiple Ascending Dose

EXPERIMENTAL

multiple ascending doses administered orally for 14 days.

Drug: SUVN-I6107; Drug: Placebo

Interventions

SUVN-I6107 DRUG

SUVN-I6107 Tablet

Multiple Ascending Dose; Single Ascending Dose

Placebo DRUG

A look-alike tablet with no active ingredient.

Multiple Ascending Dose; Single Ascending Dose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index (BMI): 18.0 to 30.0 kg/m2 for Segment 1 and 18.0 to 32.0 kg/m2 for Segment 2, inclusive, at screening and weight at least 50 kg and no more than 100 kg.
• Ability and willingness to abstain from alcohol-, caffeine-, and methylxanthine-containing beverages or food (eg, coffee, tea, cola, chocolate, energy drinks) from 48 hours (2 days) prior to each admission to the clinical facility until study discharge.
• All values for hematology and clinical chemistry tests of blood and urine within the normal range or showing no clinically relevant deviations, as judged by the Investigator, at screening and at admission.

You may not qualify if:

• Females who are pregnant, lactating, planning to become pregnant, or planning to donate ova/oocytes during this study or within 30 days after last administration of study drug.
• Males with female partners who are pregnant, lactating, or planning to become pregnant during this study or within 90 days after dosing of study drug.
• Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of admission to the clinical site.

Sponsors & Collaborators

• Suven Life Sciences Limited: lead

Study Sites (1)

Clinical Research Site

San Antonio, Texas, 78209, United States

RECRUITING

Central Study Contacts

Ramakrishna Nirogi

CONTACT

+9140 2319 3956; nvsrk@suven.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 26, 2024
• Study Start: January 7, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)